Acalabrutinib

Ontario is the first province to fund Tagrisso for patients with non-small cell lung cancer, and Calquence for patients with previously untreated mantle cell lymphoma MISSISSAUGA, ON , Jan. 23, 2026 /CNW/ - AstraZeneca Canada is pleased to announce that Tagrisso® (osimertinib) and Calquence® (acalabrutinib tablets) are now publicly funded in Ontario and are among the first therapies to receive accelerated access through the province's new Funding Accelerated for Specific Treatments (FAST) program. With the introduction of FAST, the Government of Ontario has taken a significant step toward accelerating access to cancer medicines – demonstrating its commitment to putting patients first and embracing innovation so that life-changing treatments can reach those who need them, faster than ever. "For every Ontarian facing a cancer diagnosis, timely access to high-quality treatment can make all the difference," said Sylvia Jones, Deputy Premier and Minister of Health. "Through the FAST program, our government is accelerating access to life-saving therapies including, Tagrisso and Calquence, bringing hope, peace of mind, and transformative care to those who need it most." Following recent positive reimbursement recommendations from the Canadian Drug Agency (CDA-AMC), Tagrisso is publicly reimbursed in Ontario for the treatment of patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy. 1 A validated test is required to identify EGFR mutation-positive status prior to treatment. 1 "For people living with EGFR‑mutated Stage III NSCLC, timely access to targeted treatment after chemoradiation can be life-changing," said Shem Singh, Executive Director Lung Cancer Canada. "Ontario's decision to enable access to therapies through the FAST program offers renewed hope for patients and families, and underscores how provincial leadership can shorten the path to the right care. We're hopeful other provinces will move quickly so timely, equitable access becomes a reality for patients across Canada." Following Ontario's public reimbursement of Tagrisso for this indication, it is now listed on the public formularies of Quebec and Saskatchewan. Calquence is also now publicly reimbursed in Ontario in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous stem cell transplant. 2 "MCL is a rare and often aggressive disease most commonly diagnosed in older adults who are especially vulnerable to delays in care," said Antonella Rizza, CEO, Lymphoma Canada. "We're grateful that the Ontario Government is leading the way in driving systemic change to enable quicker access to evidence-based treatments and helping reduce unnecessary wait times for patients in need." FAST includes select, high priority cancer drugs with demonstrated benefit, including therapies like Tagrisso and Calquence, approved through Project Orbis, an international partnership that involves Health Canada and is designed to give cancer patients faster access to promising treatments. This helps shorten the time between regulatory approval, reimbursement, and patient access. "This first-of-its kind program underscores the Government of Ontario's bold leadership in accelerating patient access to much-needed cancer medicines," said Gaby Bourbara, President, AstraZeneca Canada. "Public funding of Tagrisso and Calquence through FAST shows what is possible when regulators, payers, clinicians, and industry work together. We commend the province's commitment to innovation in access and remain dedicated to partnering across Canada to expand timely and equitable access to life‑changing treatments." About Tagrisso Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. The treatment is approved in Canada for the following indications: as adjuvant therapy after tumour resection in patients with stage IB-IIIA NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations; for the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations); in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced (not amenable to curative therapies) or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations; for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy; and has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit, for the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy. About Calquence Calquence is a second-generation, highly selective inhibitor of Bruton's tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion. In Canada, Calquence (acalabrutinib tablets) is approved in combination with venetoclax for patients with previously untreated chronic lymphocytic leukemia (CLL); as monotherapy or in combination with obinutuzumab for patients with previously untreated CLL; as monotherapy for the treatment of patients with CLL who have received at least one prior therapy; in combination with bendamustine and rituximab for patients with previously untreated MCL who are ineligible for autologous stem cell transplant; and as monotherapy for the treatment of patients with MCL who have received at least one prior therapy. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. In Canada, the company employs more than 2,650 people and was recently named one of Canada's Top 100 Employers for the third consecutive year. Together, AstraZeneca's R&D Hub and the Alexion, AstraZeneca Rare Disease Development Hub – both based in Mississauga, Ontario – are leading more than 110 global and Canadian clinical studies in areas such as breast, lung and prostate cancer, COPD, chronic kidney disease, and rare disease. Visit for more information. References: 1. Canada's Drug Agency. Reimbursement recommendation: Osimertinib (Tagrisso). Canadian Journal of Health Technologies, Vol. 5, No. 9, September 2025. Available at: 2. Canada's Drug Agency. Reimbursement recommendation: Acalabrutinib (Calquence). Canadian Journal of Health Technologies, Vol. 5. No. 10. November 2025. Available at: SOURCE AstraZeneca Canada Inc.

Sanofi is scrapping plans to get one of its more advanced experimental medicines approved for a certain kind of multiple sclerosis, following negative results from a clinical trial disclosed Monday.The French pharmaceutical giant didnt release any specific data, only that its drug, tolebrutinib, failed to meet the main goal of a late-stage trial titled PERSEUS. The study enrolled 767 participants with a rarer form of MS known as primary progressive, and looked at whether tolebrutinib was any better at delaying the disabilities that typically worsen over the course of the disease.Based on these results, Sanofi will not attempt to get the drug approved in this setting. The company is also evaluating if it needs to take an impairment charge related to tolebrutinibs intangible value, given that the drug was the centerpiece of a $3.7 billion buyout. Sanofi intends to provide an update on this evaluation in January though it noted that, either way, the outcome wont impact net income or earnings per share. Its 2025 financial guidance remains unchanged.We are disappointed by todays results; however, we do believe [they] will improve our understanding of the underlying disease biology of multiple sclerosis, said Houman Ashrafian, head of Sanofis research and development, in a statement.Separately, Sanofi on Monday revealed that an approval verdict for tolebrutinib as a treatment for non-relapsing secondary progressive MS will likely come later than expected.The Food and Drug Administration had previously aimed to make a decision by Sept. 28, but pushed that deadline back by three months after Sanofi made a major amendment to its application. Now, the company suspects recent discussions with the FDA indicate a ruling wont come by the revised date of Dec. 28. Sanofi anticipates more guidance from the agency sometime in the first three months of next year.The company said it strongly believes in tolebrutinibs risk-benefit profile. In response to an FDA request, it has submitted an expanded access protocol so eligible patients with non-relapsing secondary progressive MS can get ahold of the drug.The fact that the FDA has requested an extended access program suggests the agency is comfortable with the risk/benefit for now, wrote analysts at the investment bank Jefferies, in a note to clients.The market may well write the asset off, but that seems a bit premature, the analysts added. We wonder if more share price pressure will mean more pressure on management.Tolebrutinib comes as a tablet, and is part of a class of drugs designed to inhibit Brutons tyrosine kinase, an immune system-regulating enzyme that plays a key role in the development of B cells.Those cells make antibodies that alert the body to potential threats. Research suggests a root cause of MS is antibodies mistakenly attacking the protective myelin sheaths that cloak nerve fibers.Sanofi already has one BTK-blocking drug, Wayrilz, on the market for a different autoimmune condition. So does Novartis. BTK inhibitors like Imbruvica, Calquence and Brukinsa are used to treat certain blood cancers as well. The class as a whole carries safety concerns, namely the potential for liver injury, which in recent years led the FDA to issue partial clinical holds on tolebrutinib and similar drugs from Roche, Merck KGaA and InnoCare Pharma.This fall, that Roche drug, fenebrutinib,succeeded in two large MS trials. One recruited primary progressive patients, while the other focused on the far more common relapsing form of the disease. Jefferies analysts described those readouts as a positive surprise, though they also questioned whether Roche had collected enough supportive evidence to file for approval. '